Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
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|ClinicalTrials.gov Identifier: NCT03828136|
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Cervical Disc Disease||Device: Bio2 Vitrium® Cervical Interbody Device Device: Allograft Cage||Not Applicable|
The study will evaluate if Bio2 Vitrium® Cervical Interbody Device (VCIBD) is non-inferior to allograft cage in single-level ACDF with the use of local autologous bone. VCIBD is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C3/C4 disc space to the C7/T1 disc space. The material used to manufacture the implant is 13-93 bioactive glass, which is a silicate-based material as described in ASTM F1538-03(R2017). The implant has high porosity and strength and does not contain any biological material or constitute a combination product. The device has a central lumen for packing with autograft. VCIBD is intended to be used with a supplemental fixation system.
The device, when placed between the vertebrae, provides mechanical stability and prevents subsidence prior to bone ingrowth. It restores and maintains the intervertebral space during the fusion process. The porosity and material characteristics provide an osteoconductive matrix that supports bone ingrowth. Additional stabilization is provided by supplemental fixation using anterior cervical plate. The implant incorporates a central lumen, which allows for the cage to be packed with autogenous bone graft.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A total of 168 patients will be randomized in 7:2 ratio to Investigational (n=130) and Control arms (n=38).|
|Official Title:||Safety and Effectiveness of Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2024|
Experimental: ACDF with Bio2 Vitrium® Cervical Interbody Device
A resorbable cervical interbody cage.
Device: Bio2 Vitrium® Cervical Interbody Device
For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
Other Name: Bio2 Vitrium® Cervical Cage
Active Comparator: ACDF with Allograft Cage
Structural allograft ring made from structural corticocancellous allograft bone.
Device: Allograft Cage
Standard of Care
- Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination. [ Time Frame: 12 months ]Successful fusion is based on meeting the roentgenographic examination criteria showing the evidence of: bridging trabecular bone between the involved motion segments; translation motion <3mm; and angular motion ≤2°.
- Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline. [ Time Frame: 12 months ]NDI consists of ten items addressing function activities, pain intensity, concentration, and headache.It has a continuous various with a range from 0 (best) to 100 (worse). The effectiveness endpoint is the difference between the baseline value and the follow-up (12 month) value.
- Number of participants with neurological success. [ Time Frame: 12 months ]
Neurological success is a binary outcome as follows:
- Maintenance or improvement of the neurological status;
- Worsening of the neurological status.
Worsening of the neurological status is defined as permanent new neurologic damage or permanent new nerve root injury related to the surgically treated level, defined as one or more:
- Permanent decrease in one or more grades of motor strength compared to baseline;
- Permanent new sensory deficit (paresthesia or anesthesia) in a specific cervical nerve root distribution.
- Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI). [ Time Frame: 12 months ]Identified as the absence of revision, removal, reoperation, or supplemental fixation at the index level
- Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale [ Time Frame: 6, 12, and 24 months ]Neck pain and arm/shoulder pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
- Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2) [ Time Frame: 6, 12, and 24 months ]The SF-36v2 Health Survey is a 36-item instrument for measuring health status and outcomes. It yields an eight-scale profile score from the following eight health concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and general mental health (psychological distress and psychological well being). In addition, two composites scores are constructed using factorial modeling, one from physical health composite score (PCS) and one for mental health composite score (MCS).
- Quality of Life assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 3 Levels (EQ-5D-3L) [ Time Frame: 6, 12, and 24 months ]The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
- Measurement of the use of Pain Medication for Cervical Spine. [ Time Frame: 6, 12, and 24 months ]The use of prescription and OTC pain medication for cervical spine-related pain will be recorded in addition to the use of opioids on study-specific logs.
- Measurement of Patient Satisfaction: patients to rate their satisfaction [ Time Frame: 6, 12, and 24 months ]Developed based on IDE spine studies. It asks patients to rate their satisfaction with their treatment (6 choices from "Very Satisfied" to "Very Dissatisfied"), and question regarding every day activities and their ability to complete them. There are 5 choices from "Definitely" to "Definitely Not".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828136
|Contact: Janet Krevolinfirstname.lastname@example.org|